Basiliximab

What is Basiliximab?

• Basiliximab (Simulect) is a chimeric (murine/human) monoclonal antibody (IgG1к), produced by recombinant DNA technology, that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin-2 receptor α-chain (IL-2Rα, also known as CD25 antigen) on the surface of activated T-lymphocytes.

What are the uses of this medicine?

• Basiliximab (Simulect) is used as the prophylaxis of acute organ rejection in patients receiving kidney transplants.
• when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED), and corticosteroids.

Limitations of use:

• The efficacy of Simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.

How does this medicine work?

• Basiliximab (ba” si lix’ i mab) is a recombinant humanized monoclonal IgG1 kappa antibody to the alpha subunit of the IL2 receptor (CD25). The IL2 receptor is found on T cells and its engagement results in activation of T cells and generation of pro-inflammatory cytokines.
• Inhibition of the receptor with antibody results in prevention of activation and proliferation of T cells and inhibition of T cell responses. Basiliximab has been shown to decrease the rate of acute cellular rejection after solid organ transplantation and to improve long term graft and patient survival.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• with known hypersensitivity to basiliximab or any other component of the formulation.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Basiliximab was approved for use in the United States in 1998 for renal transplantation and continues to be used, typically in induction regimens starting at the time of or shortly before transplantation.
• It is also used off-label for liver, heart and lung transplantation.

How should this medicine be used?

• Simulect® (basiliximab) is used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED) and corticosteroids.

Recommended dosage: Adults:

• In adult patients, the recommended regimen is two doses of 20 mg each.
• The first 20-mg dose should be given within 2 hours prior to transplantation surgery.
• The recommended second 20-mg dose should be given 4 days after transplantation.
• The second dose should be withheld if complications, such as severe hypersensitivity reactions to Simulect or graft loss occur.

Pediatric:

• In pediatric patients weighing less than 35 kg, the recommended regimen is two doses of 10 mg each.
• In pediatric patients weighing 35 kg or more, the recommended regimen is two doses of 20 mg each.
• The first dose should be given within 2 hours prior to transplantation surgery.
• The recommended second dose should be given 4 days after transplantation.
• The second dose should be withheld if complications, such as severe hypersensitivity reactions to Simulect or graft loss occur.

Administration:

• Basiliximab injection comes as a powder to be mixed with water and injected intravenously by a doctor or nurse in a hospital or medical facility.
• It is usually given as 2 doses.
• The first dose is usually given 2 hours before the transplant surgery, and the second dose is usually given 4 days after the transplant surgery.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As single-dose vials and is available in 10 mg and 20 mg strengths for intravenous administration after reconstitution.

This medicine is available in fallowing brand namesː

• Simulect

What side effects can this medication cause?

The most common side effects of this medicine include:

• infusion reactions, chills, fever, skin rash, fatigue, diarrhea, nausea, headache, anorexia, leukopenia and infections

• Rare, but potentially severe side effects include acute hypersensitivity reactions, anaphylaxis, capillary leak syndrome, cytokine release syndrome and progressive multifocal leukoencephalopathy.

What special precautions should I follow?

• Simulect® (basiliximab) should be administered under qualified medical supervision. Patients should be informed of the potential benefits of therapy and the risks associated with administration of immunosuppressive therapy.
• Severe acute (onset within 24 hours) hypersensitivity reactions, including anaphylaxis have been observed both on initial exposure to Simulect and/or following re-exposure after several months. These reactions may include hypotension, tachycardia, cardiac failure, dyspnea, wheezing, bronchospasm, pulmonary edema, respiratory failure, urticaria, rash, pruritus, and/or sneezing. If a severe hypersensitivity reaction occurs, therapy with Simulect should be permanently discontinued. Medications for the treatment of severe hypersensitivity reactions, including anaphylaxis should be available for immediate use.
• It is not known whether Simulect® (basiliximab) use will have a long-term effect on the ability of the immune system to respond to antigens first encountered during Simulect-induced immunosuppression.
• It is not known whether Simulect is excreted in human milk.
• Do not have any vaccinations without talking to your doctor.
• Basiliximab has not been linked to serum enzyme elevations during therapy or implicated in cases of clinically apparent liver injury.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies in pregnant women.
• Basiliximab should only be used in pregnant women when the potential benefit justifies the potential risk to the fetus.
• Women of childbearing potential should use effective contraception before beginning basiliximab therapy, during therapy, and for 4 months after completion of basiliximab therapy.

Can this medicine be used in children?

• Safety and effectiveness have been established in the pediatric population.
• In pediatric patients weighing less than 35 kg, the recommended regimen is two doses of 10 mg each.
• In pediatric patients weighing 35 kg or more, the recommended regimen is two doses of 20 mg each.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• BASILIXIMAB

Inactive ingredients:

• SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
• GLYCINE
• MANNITOL
• POTASSIUM PHOSPHATE, MONOBASIC
• SODIUM CHLORIDE
• SUCROSE

Who manufactures and distributes this medicine?

Manufactured by:

• Novartis Pharmaceuticals Corporation
• East Hanover, New Jersey

What should I know about storage and disposal of this medication?

• Store lyophilized Basiliximab under refrigerated conditions at 2ºC to 8ºC (36ºF to 46ºF).
• Do not use beyond the expiration date stamped on the vial.

The following drugs used to prevent transplant rejection.

Immunosuppressants

• Cyclosporine
• Everolimus
• Mycophenolate
• Sirolimus
• Tacrolimus

Monoclonal Antibodies

• Alemtuzumab
• Basiliximab
• Daclizumab
• Muromonab

Antithymocyte Globulin

• Dailymed label info on Basiliximab
• FDA Basiliximab

Basiliximab Resources
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